Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology company
developing transformative therapeutics, today announced recent
corporate updates and financial results for the third quarter ended
September 30, 2020.
“Aravive has made continued progress executing on our strategic
initiatives in the third quarter of 2020, including strengthening
our leadership team, expanding our Board of Directors and advancing
our development plans for AVB-500,” said Gail McIntyre, Ph.D.,
chief executive officer of Aravive. “We expect to initiate a
pivotal trial of AVB-500 in platinum resistant ovarian cancer
during the fourth quarter of 2020 or in the first quarter of 2021
and are on-track to initiate a Phase 1b/2 trial of AVB-500 in clear
cell renal cell carcinoma this year. We are very encouraged by the
AVB-500 clinical trial results to date, and are well-positioned to
continue to advance both the ovarian cancer and renal cancer
programs.”
Recent Corporate
Highlights
- AVB-500 in Platinum Resistant Ovarian
Cancer (PROC): Aravive expects to initiate a pivotal trial
for AVB-500 in PROC during the fourth quarter of 2020/first quarter
of 2021. The study is expected to be a global, randomized,
double-blind, placebo-controlled trial to evaluate efficacy and
tolerability of AVB-500 at a dose of 15 mg/kg in combination with
paclitaxel.
- AVB-500 in Clear Cell Renal Cell Carcinoma
(ccRCC): Aravive is
on-track to initiate a Phase 1b/2 trial of AVB-500 in ccRCC during
the fourth quarter of 2020. This is an open-label study which is
expected to provide safety, pharmacokinetic, and preliminary
clinical activity in 2021.
- Strengthened Leadership Team: The Company
enhanced its clinical development and oncology expertise with the
appointments of Reshma Rangwala, M.D., Ph.D., as Chief Medical
Officer, Randy Anderson, Ph.D., as Senior Vice President of Data
Sciences, Elisabeth Gardiner, Ph.D., as Vice President of
Translational Medicine, and Patrick Simms, as Vice President of
Clinical Operations.
- Expanded Board of Directors: Aravive appointed
Michael W. Rogers, a biopharmaceutical veteran and healthcare
leader with more than 20 years of public company financial
experience, to the Company’s Board of Directors. Mr. Rogers serves
as Chair of Aravive’s Audit Committee.
Third Quarter 2020
Financial ResultsRevenue for the three and nine
months ended September 30, 2020 were $0 for both periods, compared
to $0 and $4.8 million for the same periods in 2019. Revenue for
2019 was derived solely from the Cancer Prevention Research
Institute of Texas (CPRIT) grant.
Total operating expenses for the three and nine months ended
September 30, 2020 were $10.7 million and $26.7 million,
respectively, compared to $7.0 million and $21.4 million for the
same periods in 2019.
Total operating expenses for the three and nine months ended
September 30, 2020 included non-cash stock-based compensation
expense of $0.4 million and $1.6 million, respectively, compared to
$0.8 million and $2.8 million for the same periods in 2019. In
addition, during the three and nine months ended September 30,
2020, there was a non-recurring non-cash charge for impairment of
the Company’s right-of-use asset and leasehold improvements of $2.9
million and $5.8 million, respectively.
For the three and nine months ended September 30, 2020, Aravive
reported a net loss of $10.7 million and $26.5 million, or $0.66
per share and $1.69 per share, respectively, compared to a net loss
of $6.1 million and $13.9 million, or $0.54 per share and $1.23 per
share, for the same periods in 2019.
Cash PositionAs of September 30, 2020, cash and
cash equivalents was $54.0 million, compared to $65.1 million as of
December 31, 2019. The Company expects that its current cash and
cash equivalents will be sufficient to fund its operating plans
into 2022.
About AraviveAravive, Inc. is a
clinical-stage oncology company developing transformative
therapeutics designed to halt the progression of life-threatening
diseases. Aravive’s lead therapeutic, AVB-500, is an ultra-high
affinity decoy protein that targets the GAS6-AXL signaling pathway
associated with tumor cell growth. Aravive recently successfully
completed a Phase 1b trial of AVB-500 in platinum resistant ovarian
cancer and selected 15 mg/kg as the dose for the pivotal trial.
Analysis of all safety data to date showed that AVB-500 has been
generally well-tolerated with no dose-limiting toxicities or
unexpected safety signals. While the Phase 1b trial of AVB-500 in
platinum resistant ovarian cancer was a safety trial and not
powered to demonstrate efficacy, all 5 patients in the 15 mg/kg
cohort experienced clinical benefit, with 1 complete response, 2
partial responses, and 2 stable disease. The Company also intends
to initiate a Phase 1b/Phase 2 trial of AVB-500 in clear cell renal
cell carcinoma later this year. For more information, please
visit www.aravive.com.
Forward-Looking StatementsThis communication
contains forward-looking statements (including within the meaning
of Section 21E of the United States Securities Exchange Act of
1934, as amended, and Section 27A of the United States Securities
Act of 1933, as amended), express or implied, such as initiation of
a pivotal trial of AVB-500 in platinum resistant ovarian cancer
during the fourth quarter 2020/first quarter 2021, initiation of
Phase 1b/2 trial of AVB-500 in clear cell renal cell
carcinoma during the fourth quarter of 2020, the pivotal trial
of AVB-500 in platinum resistant ovarian cancer being a global,
randomized, double-blind, placebo-controlled trial to evaluate
efficacy and tolerability of AVB-500 at a dose of 15 mg/kg in
combination with paclitaxel, the Phase 1b/2 trial of AVB-500 in
clear cell renal cell carcinoma providing safety, pharmacokinetic,
and preliminary clinical activity in 2021 and current cash and cash
equivalents expected to fund operations into 2022. Forward-looking
statements are based on current beliefs and assumptions, are not
guarantees of future performance and are subject to risks and
uncertainties that could cause actual results to differ materially
from those contained in any forward-looking statement as a result
of various factors, including, but not limited to, risks and
uncertainties related to: the Company's ability to design and
obtain approval for a randomized, double-blind, placebo-controlled
trial to evaluate efficacy and tolerability of AVB-500 at a dose of
15 mg/kg in combination with paclitaxel, the ability to properly
fund the Company, the ability to initiate the open-label ccRCC
study and expected pivotal PROC study within the expected
timelines, the ability to provide preliminary safety,
pharmacokinetic and preliminary clinical activity from the ccRCC
study in 2021, the ability to fund operations into 2022 with
current cash and cash equivalents, the ability of the new directors
and management team to deliver on the Company's strategic vision
and execute on its business plan, the impact of COVID-19 on the
Company's clinical strategy, clinical trials, supply chain and
fundraising, the Company's ability to expand development into
additional oncology indications, the Company's dependence upon
AVB-500, AVB-500's ability to have favorable results in clinical
trials and ISTs, the clinical trials of AVB-500 having results that
are as favorable as those of preclinical and clinical trials, the
ability to receive regulatory approval, potential delays in the
Company's clinical trials due to regulatory requirements or
difficulty identifying qualified investigators or enrolling
patients especially in light of the COVID-19 pandemic; the risk
that AVB-500 may cause serious side effects or have properties that
delay or prevent regulatory approval or limit its commercial
potential; the risk that the Company may encounter difficulties in
manufacturing AVB-500; if AVB-500 is approved, risks associated
with its market acceptance, including pricing and reimbursement;
potential difficulties enforcing the Company's intellectual
property rights; the Company's reliance on its licensor of
intellectual property and financing needs. The foregoing review of
important factors that could cause actual events to differ from
expectations should not be construed as exhaustive and should be
read in conjunction with statements that are included herein and
elsewhere, including the risk factors included in the Company's
Annual Report on Form 10-K for the fiscal year ended December 31,
2019, recent Current Reports on Form 8-K and subsequent filings
with the SEC. Except as required by applicable law, the Company
undertakes no obligation to revise or update any forward-looking
statement, or to make any other forward-looking statements, whether
as a result of new information, future events or otherwise.
| |
|
Aravive, Inc.Condensed Consolidated
Statements of Operations(in thousands, except per share
amounts)(unaudited) |
| |
|
|
|
|
| |
Three Months Ended |
|
Nine Months Ended |
|
| |
September 30, |
|
September 30, |
|
| |
2020 |
|
2019 |
|
2020 |
|
2019 |
|
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant revenue |
$ |
— |
|
$ |
— |
|
$ |
— |
|
$ |
4,753 |
|
| Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
5,070 |
|
|
3,840 |
|
|
11,085 |
|
|
10,325 |
|
|
General and administrative |
|
2,715 |
|
|
3,158 |
|
|
9,866 |
|
|
11,039 |
|
|
Loss on impairment of long-lived assets |
|
2,914 |
|
|
— |
|
|
5,784 |
|
|
— |
|
| Total operating expenses |
|
10,699 |
|
|
6,998 |
|
|
26,735 |
|
|
21,364 |
|
| Loss from operations |
|
(10,699 |
) |
|
(6,998 |
) |
|
(26,735 |
) |
|
(16,611 |
) |
| Interest income |
|
8 |
|
|
232 |
|
|
251 |
|
|
811 |
|
| Other income (expense),
net |
|
31 |
|
|
624 |
|
|
(13 |
) |
|
1,910 |
|
| Net loss |
$ |
(10,660 |
) |
$ |
(6,142 |
) |
$ |
(26,497 |
) |
$ |
(13,890 |
) |
| Net loss per share- basic and
diluted |
$ |
(0.66 |
) |
$ |
(0.54 |
) |
$ |
(1.69 |
) |
$ |
(1.23 |
) |
| Weighted-average common shares
used to compute basic and diluted net loss per share |
|
16,055 |
|
|
11,285 |
|
|
15,658 |
|
|
11,280 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Aravive, Inc.Condensed Consolidated
Balance Sheets (in thousands) |
| |
|
|
|
|
| |
September 30, |
|
December 31, |
|
| |
2020 |
|
2019 |
|
| |
(unaudited) |
|
|
|
|
|
Assets: |
|
|
|
|
|
|
| Cash and cash equivalents |
$ |
53,967 |
|
$ |
65,134 |
|
| Restricted cash |
|
2,430 |
|
|
2,423 |
|
| Other assets |
|
2,182 |
|
|
5,867 |
|
| Operating lease right-of-use
assets |
|
2,651 |
|
|
8,697 |
|
| Total
assets |
$ |
61,230 |
|
$ |
82,121 |
|
| Liabilities and stockholders'
equity: |
|
|
|
|
|
|
| Accounts payable and accrued
liabilities |
$ |
3,162 |
|
$ |
2,575 |
|
| Operating lease
obligation |
|
8,407 |
|
|
10,233 |
|
| Contingent payable |
|
295 |
|
|
264 |
|
| Total liabilities |
|
11,864 |
|
|
13,072 |
|
| Total stockholders'
equity |
|
49,366 |
|
|
69,049 |
|
| Total liabilities and
stockholders’
equity |
$ |
61,230 |
|
$ |
82,121 |
|
| |
|
|
|
|
|
|
Contacts:Investors:Luke Heagle, W2O
lheagle@w2ogroup.com (910) 726-1372
Media:Sheryl Seapy, W2Osseapy@w2ogroup.com(949) 903-4750
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